Senior Manager, Regulatory Affairs Labeling

The Opportunity:

The Senior Manager of Labeling serves as a labeling support strategist, partnering with the Global Labeling Lead to execute global labeling deliverables for assigned products. The role develops and maintains regional labeling using the Company Core Data Sheet (CCDS) or an approved reference regional label, adapting content to applicable local requirements while preserving alignment with global labeling strategy. The Senior Manager prepares labeling documents directly or oversees their preparation by external vendors. In both cases, the individual is accountable for document quality, timely delivery, and management of all required cross-functional review and approval activities through completion, in accordance with company procedures and designated approval authorities.

The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel.

Labeling Development and Strategic Support

• Partner with the Global Labeling Lead to translate global labeling strategy into actionable regional and country labeling plans, including deliverables, dependencies, timelines, and review requirements.

• Author, revise, and maintain regional prescribing information and patient labeling, as applicable, using the CCDS or an approved reference regional label and relevant supporting documentation

• Assess the impact of CCDS changes, reference label updates, new clinical or safety information, and health authority feedback on assigned labeling; coordinate required updates with regional Regulatory Affairs.

• Identify and document differences between proposed local labeling and the CCDS or reference label. Develop recommendations and coordinate review, escalation, and approval of deviations through established governance processes.

• Responsible for proofreading and departmental QC work; ensure quality of labeling deliverables.

Vendor Oversight

• Define the scope, source documents, content expectations, timelines, and quality standards for outsourced labeling activities; provide clear instructions and ongoing guidance.

• Review vendor-prepared documents for accuracy, completeness, consistency with source labeling, and alignment with applicable requirements. Ensure comments are resolved and deliverables are ready for internal review and approval.

• Monitor vendor performance and escalate quality, resource, or timeline concerns to relevant vendor management stakeholders.

Review and Approval Management

• Own coordination of required reviews and approvals for assigned labeling, regardless of whether documents are authored internally or by a vendor. Identify reviewers and approvers, establish schedules, and manage review and approval workflows through completion.

• Facilitate cross-functional review, consolidate feedback, resolve comments, and drive alignment on proposed content.

• Prepare review materials, document decisions and their rationale, and escalate unresolved content or strategic issues to the Global Labeling Lead.

• Ensure required approvals are obtained and recorded before documents are released for submission or implementation; maintain approved versions, annotations, supporting references, and an auditable decision history.

Delivery and Process Improvement

• Coordinate with regional and local Regulatory Affairs and Regulatory Operations to provide approved labeling for submission, support responses to labeling queries, and track implementation status.

• Maintain accurate project trackers and controlled document repositories; communicate progress, risks, and mitigation plans. Support inspection readiness and improvements to labeling procedures, templates, and vendor workflows.

Required Skills, Experience and Education:

• Bachelor’s degree in scientific, pharmacy, life sciences, or related discipline.

• At least 7+ years of pharmaceutical or biotechnology industry experience supporting regulatory labeling in at least two or more major geographic areas.

• Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements.

• Demonstrated experience preparing regional labeling from a CCDS or reference label and managing cross-functional document review and approval.

• Experience overseeing external labeling vendors, managing labeling deviations, and supporting labeling submissions across multiple regions.

• Experience with electronic document management and regulatory information management systems, including controlled review workflows, version control, and approval records.

• Detail oriented and highly organized with the ability to deliver against tight timelines.

• Strong project management and communication; ability to manage competing priorities and resolve issues in a global matrix organization.

Preferred Skills:

• Advanced degree in science or other related discipline.

• 9+ years in the biotech or pharmaceutical industry leading the development/maintenance of product labeling across two or more major geographic areas.

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